Kornimate/medical-research-clean huggingface dataset:
impact of left atrial appendage exclusion on short-term clinical outcomes and long-term stroke incidence

Conditions: Atrial Fibrillation; Thromboembolism; Cerebrovascular Accident

Summary: stroke is a major cause of morbidity in western society, and an infrequent complication of cardiac surgery. the majority of thromboembolic strokes arise from the left atrium, in particular the left atrial appendage. this study aims to assess the short-term effects of left atrial appendage ligation in terms of postoperative clinical and biochemical parameters; and the long-term effects of left atrial appendage ligation in terms of stroke incidence.

in patients with non-rheumatic atrial fibrillation, the left atrial appendage is the origin of at least 90% of all left atrial clots, and the resulting systemic emboli cause approximately 25% of all strokes. the stroke rate in patients with atrial fibrillation older than 75 years of age is 8.1% per year with one clinical risk factor and is 12% per year at any age in clinical trial populations with a history of prior thromboembolism. three-year stroke rates in elderly nursing home patients not anticoagulated are in excess of 50% (atrial fibrillation investigators 1994). anticoagulation is oftentimes withheld due to the perception of excessive risk in case of a fall; even when anticoagulation is prescribed, it is well known that therapeutic levels are not always maintained. left atrial appendage obliteration is commonly performed in a variety of cardiac surgical operations. there have been animal studies and theoretical arguments which demonstrate the importance of the atrial appendage in its role to support cardiac output and blood pressure, and modulate thirst and hypercoagulability (stollberger 2003); however this has been poorly studied and documented in humans in the available literature. bnp and anp have been shown to increase proportionately with left atrial appendage dysfunction, as have von willebrands factor, d-dimer, and thrombin-antithrombin iii complex (igarashi 2001). to date, there is not a single randomized controlled trial with adequate follow-up to assess the short- and long-term clinical effectiveness of concurrent prophylactic laa ligation. this trial will fill that void.

Eligibility criteria:
inclusion criteria: * patients undergoing mitral valve repair or replacement surgery exclusion criteria: * patients undergoing concurrent surgical anti-arrythmia procedure * heart transplant patients * patients with known hematologic hypercoagulability disorder

Keywords: atrial fibrillation left atrial appendage surgical ligation thromboembolism cerebrovascular accident
post market surveillance for infanrix™

Conditions: Diphtheria; Acellular Pertussis; Tetanus

Summary: the purpose of this study was to investigate the following questions through post-marketing surveillance: * unknown/unexpected adverse events and the serious adverse events. * the circumstances in which the adverse events occurred under the practical application. * factors considered to have influence on safety. * factors considered to have influence on efficacy. * miscellaneous - facts about mechanism, efficacy and safety which were not clearly known due to the inherent problems of the drugs.


Eligibility criteria:
inclusion criteria: all children receiving infanrix™ were eligible for this survey. exclusion criteria:
effect of rtb101 on illness associated with respiratory tract infections in the elderly

Conditions: Clinically Symptomatic Respiratory Illness

Summary: the purpose of this study is to determine if rtb101 prevents illness associated with respiratory tract infections in people ≥65 years of age.

rtb-101-205 is a randomized, double-blind, placebo-controlled, multicenter, parallel-group, phase 3 study to determine if rtb101, a selective torc1 inhibitor, prevents illness associated with respiratory tract infections (defined as clinically symptomatic respiratory illness) in adults ≥65 years of age. this trial is being conducted in follow up to two phase 2 trials in older adults in which rtb101 10 mg administered once daily for up to 16 weeks during winter cold and flu season was observed to reduce the incidence of respiratory illness associated with respiratory tract infections.

Eligibility criteria:
inclusion criteria: * subjects must be ≥65 years of age * subjects should require no or minimal assistance with self-care and activities of daily living. subjects in assisted-living or long-term care residential facilities that provide minimal assistance are eligible * sexually active male subjects with a partner of child-bearing potential must be willing to wear a condom while on study drug and for 1 week after stopping study drug and should not father a child in this period exclusion criteria: * subjects who are current smokers, stopped smoking ≤ 1 year prior to screening, or have and a ≥ 10 pack year smoking history * subjects with a medical history of clinically significant lung diseases (including copd) other than asthma * subjects with current evidence of a serious and/or unstable medical disorder * subjects with unstable cardiac conditions * subjects with a history of systemic autoimmune diseases * subjects with type i diabetes mellitus * subjects with a history of immunodeficiency diseases, including a positive human immunodeficiency virus (hiv) test result * infection with hepatitis b (hbv) or hepatitis c (hcv)

Keywords: mechanistic target of rapamycin (mtor) influenza virus pneumonia immunosenescence respiratory tract infections
postprandial dysmetabolism

Conditions: Type 2 Diabetes Mellitus

Summary: type 2 diabetes (t2d) is a common disease associated with multiple complications and an increased risk of cardiovascular morbidity and mortality. also, it is a heavy economical burden on society. 1st degree relatives of patients with t2d have an increased risk of developing t2d. this risk can be modified by the ingested diet: a traditional north european diet rich in saturated fat increases the risk, while a mediterranean diet rich in monounsaturated fat protects from development of t2d and cardiovascular disease. t2d is a part of the metabolic syndrome consisting of t2d, hypertension, adipositas, dyslipidemia and steatosis. the pathogenesis of the metabolic syndrome is partly explained by fasting dyslipidemia, postprandial dysmetabolism (derangement of lipid and carbohydrate metabolism) and impaired metabolic flexibility. partly, it can be explained by a chronic low-grade inflammation in peripheral tissue. the dysmetabolism and the inflammation are correlating entities exerting their influence through common biochemical pathways. this is established in patients with t2d, but sparsely studied in healthy relatives of patients with t2d. in this project, the investigators will study postprandial dysmetabolism, inflammation, oxidative stress, adipocytokines, incretins, appetite regulating hormones and the expression of the genes involved in above mentioned. we will compare healthy 1st degree relatives of patients with t2d with healthy controls with no family history of t2d and look into differences in the response to meal stimulation with respectively saturated and monounsaturated fat. the subjects will be thoroughly examined with a hyperinsulinaemic euglycaemic clamp and a dexa scan. before and after the meal stimulation, we will perform calorimetry (in order to determine the metabolic rates), take blood samples and perform muscle and fat tissue biopsies. the biopsies will be used for studies of a vast number of genes. the project will give us new valuable knowledge about the interaction between the intermediate metabolism and the innate immune system and the early pre-diabetic changes in the 1st degree relatives of patients with t2d. in the long run, the project will contribute to improving our guidance and treatment of persons at risk of developing t2d.


Eligibility criteria:
inclusion criteria: * relatives: minimum 2 1st degree relatives with type 2 diabetes or 1 one 1st degree relative with type 2 diabetes and history of gestational diabetes. * controls: no family history of type 2 diabetes and fasting blood glucose \<6.0 mm. exclusion criteria: * cardiovascular, renal or endocrine disease. * treatment with steroids. * psychiatric history. * abuse of alcohol or narcotics. * smoking. * pregnancy or breast-feeding.

Keywords: type 2 diabetes mellitus postprandial dysmetabolism postprandial inflammation relatives meal challenge
effects of triclosan-coated sutures in cardiac surgery

Conditions: Postoperative Wound Infection

Summary: the purpose of this study is to assess if triclosan-coated sutures reduces wound infections after saphenous vein harvesting in cabg patients. secondary objectives are the effect triclosan-coated sutures on sternal wound infections and a cost analysis.

the role of the suture material for the development of postoperative wound infection has been debated for many years. it has been reported that fewer bacteria adhere to monofilament polypropylene than braided polyester sutures in vitro but the results are opposed by a non-randomized clinical study where the use of monofilament sutures was identified as an independent risk factor for leg wound infections after cabg.

Eligibility criteria:
inclusion criteria: * patients undergoing elective cabg at sahlgrenska university hospital with intended use of saphenous vein graft are included. exclusion criteria: * patients with on-going sepsis or septicaemia, bacterial infections or known allergy to triclosan are excluded.

Keywords: wound infection ssi suture
intraoperative dialysis in liver transplantation

Conditions: Liver Failure; Acute Kidney Disease; Multi-organ Failure

Summary: patient with liver failure waiting for liver transplantation are often hospitalized and commonly supported in an intensive care unit prior to surgery. these patients are sick, and in addition to the complications of a failing liver, other organs such as the kidneys often fail as well. as a consequence, these patients are at an increased risk for complications related to their kidney failure during their liver transplantation procedure. one potential method to diminish the risk of these complications is to provide dialysis support to these patients during their liver transplantation in the operating theater in the form of continuous renal replacement therapy (crrt). while this is increasingly being performed and is theoretically appealing, there is very little information to support this practice. in addition, the use of crrt during surgery is not entirely without risk. the investigators have performed two preliminary studies on the use of crrt during liver transplantation and our data would strongly support the need to conduct further higher-quality studies to better evaluate its feasibility, safety and usefulness. our proposed study is for a randomized trial comparing the use of crrt during surgery with standard supportive care in sick patients with liver failure scheduled to receive a liver transplantation.


Eligibility criteria:
inclusion criteria: * consent * adult (age \> 18 years on the day of assessment of eligibility) * planned cadaveric orthotopic liver transplantation * pre-operative unadjusted (natural) modification of end-stage liver disease (meld) score \> 25. * pre-operative aki, defined by a minimum rifle-risk, and/or pre-operative estimated glomerular filtration rate (egfr) \<60 ml/min/1.73m2, calculated by the modification of diet in renal disease (mdrd) equation. exclusion criteria: * planned living-related donor liver transplantation * pre-operative potassium \[k\] \> 4.5 mmol/l and urine output \< 100 ml in the 6 hrs preceding assessment of eligibility * pre-operative ph \< 7.3

Keywords: liver transplantation (e04.210.650) renal replacement therapy (e05.196.353) intra-operative period (e04.614.374) safety (n06.850.135.060.075) efficacy
preoperative embolization in surgical treatment of spinal metastases.

Conditions: Spinal Metastases

Summary: the main purpose of this study is to assess the efficacy of preoperative embolization in decreasing operative blood loss, decreasing the need for intraoperative transfusion and facilitate surgical resection in metastatic spine surgery. furthermore the study aims at describing the vascularity in a series of spinal metastasis, and to correlate this with perioperative blood loss.


Eligibility criteria:
inclusion criteria: * patients scheduled for decompression and posterior thoracic and/or lumbar instrumented spinal fusion because of spinal metastasis/metastases. * informed signed consent. exclusion criteria: * contrast fluid allergy. * clotting disorders. * renal failure. * not suitable for arterial access. * pregnancy.

Keywords: preoperative embolization transcatheter arterial embolization therapeutic angiography embolization surgical blood loss spinal metastases spinal neoplasms vertebral metastases metastatic spine surgery spinal surgery
the effect of school-based bullying prevention program on bullying victimization, tendencies and future expectations of adolescents

Conditions: Bullying

Summary: the aim of this study is to determine the effect of a school-based bullying prevention program on adolescents' bullying victimization, tendencies and future expectations.

communication is one of the indispensable elements of human history. with the advancement in technology, the use of the internet, social media, and digital tools such as computers and cell phones has taken an important place in human life. children and young people use the internet for different activities such as doing educational work, exchanging messages via e-mail, playing online games, shopping, using social networks, watching movies and listening to music. it is reported that the age group with the highest rates of computer and internet use is adolescents and young adults (16-24 and 25-34 age groups). excessive and problematic use of information technologies and the transfer of relationships to virtual environments can bring about some negative situations that may occur in adolescents such as internet addiction and cyberbullying. cyberbullying, which is the deliberate and regular use of digital technology such as computers, mobile phones and the internet to harass others, includes concepts such as cyberbullying, cyberbullying and cyber victimization. bullying, which is a proactive behavioral problem, is a situation in which an individual or group repeatedly exhibits humiliating and aggressive behaviors to an individual or group that is relatively weaker than themselves. bullying and cyberbullying faced by adolescents have become an important problem worldwide.the aim of this study is to determine the effect of a school-based bullying prevention program on adolescents' bullying victimization, tendencies and future expectations.

Eligibility criteria:
inclusion criteria: * studying at şanlıurfa eyyübiye atatürk anatolian high school and agree to participate in the research exclusion criteria: * not meeting inclusion criteria

Keywords: peer, bullying, future expectation, bullying education
an exploratory investigation of a supplement to promote cognitive health benefits

Conditions: Anxiety; Stress; Memory Deficits; Cortisol Overproduction

Summary: the smart supplement has 20 vitamins and minerals that have strong track records of demonstrating positive health effects, both physiologically and cognitively. this twelve-week trial will examine the effectiveness and efficacy of heights smart supplement on both biomarkers and subjective experiences from participants.


Eligibility criteria:
inclusion criteria: * in good general health with no major chronic conditions * must experience one of the following issues: brain fog * or issues with fatigue, * or sleep issues, * or trouble with focus and concentration, * or lead a busy, stressful life. * must have a fitness tracker that they use to track sleep behaviors. * may be on a vegan/vegetarian diet exclusion criteria: * females who are pregnant or breastfeeding * anyone currently taking other supplements focused on brain health, or multi vitamins, including additional iron supplements * anyone taking thyroxine and levothyroxine * anyone taking antidepressants (such as sertraline or ssris like fluoxetine) * anyone on hormone replacement therapy * anyone taking blood pressure medication (such as linosipril) * anyone with a known allergic reaction * any chronic conditions, including oncological and psychiatric disorders

Keywords: memory stress anxiety mood focus
a study of the safety and efficacy of pancreatic endocrine cell clusters implanted into the omentum of type 1 diabetes patients with severe hypoglycemia

Conditions: Diabetes Mellitus Type 1

Summary: this study will evaluate the safety, efficacy and durability of sr-02 administered to the omentum of patients of type 1 diabetes with severe recurrent hypoglycemia. the study will also help establish the optimal treatment dose. although this study is open to patients with all hla or blood types, immunosuppression to prevent rejection will be required in this first in human study.


Eligibility criteria:
key inclusion criteria * adult 18 to 65 years with a clinical history of t1d * diagnosis of t1d at \<40 years of age * insulin dependence for ≥5 years at pre-screening * recurrent severe hypoglycemia * willingness to use continuous glucose monitoring key exclusion criteria * use of anti-diabetic agent other than insulin(s) or insulin analog(s) within 3 months of screening * weight loss medication(s) within 3 months of screening other protocol defined inclusion/exclusion criteria may apply

Keywords: severe hypoglycemia diabetes mellitus endocrine system diseases glucose metabolism disorders
long-term safety and tolerability study of adalimumab in subjects with crohn's disease

Conditions: Crohn's Disease

Summary: to evaluate the long-term maintenance of response, safety and tolerability of repeated administration of adalimumab in subjects with crohn's disease who participated in and successfully completed protocol m02-404 or protocol m04-691.


Eligibility criteria:
inclusion criteria: * subject must have successfully completed either the m02-404 (nct00077779) or m04-691 (nct00105300) protocol to be eligible for this study * diagnosis of crohn's disease * willing and able to give informed consent exclusion criteria: * diagnosis of ulcerative colitis * women cannot be pregnant or breastfeeding * previous history of listeria infection or untreated tuberculosis * previous history of cancer other than successfully treated skin cancer or carcinoma-in-situ of the cervix
dfi and aneuploidies

Conditions: Embryo Disorder

Summary: ivf is the most commonly employed form of assisted reproductive technologies (art) for the 10-15% of couples who face difficulties becoming pregnant. many individuals elect to have their ivf-derived embryos analyzed using pregenetic implantation testing for aneuploidies (pgt-a). the use of pgt-a is particularly beneficial for patients at higher risk for aneuploidy, such as those of advanced maternal age and those faced with recurrent pregnancy loss or recurrent implantation failure. segmental aneuploidies are generated when a small piece of a chromosome is gained or lost during cell division, resulting in subchromosomal copy number (cn) changes. the frequency of segmental aneuploidies during the cleavage stage varies between studies, from as low as 3.9% to 15% and up to 70 % with no reported correlation with maternal age. this can be explained by the fact that, unlike whole chromosome aneuploidies, segmental aneuploidies most often involve paternally inherited chromosomes.


Eligibility criteria:
inclusion criteria: * ivf cycle completed at clinique ovo * maternal age between 18 to 43 years included * pgt-a done on all embryos * recent dfi within 1 year of the ivf cycle exclusion criteria: * sperm donation
dichloroacetate kinetics, metabolism and toxicology

Conditions: Lactic Acidosis

Summary: dichloroacetate (dca) is a product of water chlorination and a metabolite of certain industrial solvents, thus making it a chemical of environmental concern. however, dca is also used as an investigational drug for treating various diseases of adults and children, at doses far greater than those to which humans are normally exposed in the environment. our research involves how dca is metabolized by healthy adults and by children with a fatal genetic disease, congenital lactic acidosis (cla) who are treated with dca.


Eligibility criteria:
children with congenital lactic acidosis healthy adult volunteers

Keywords: dichloroacetate chlorinated hydrocarbons genetic disease toxicology biotransformation
small airway chronic obstructive disease syndrome following exposure to wtc dust

Conditions: Chronic Obstructive Pulmonary Disease; Lower Respiratory Disease

Summary: many "survivors" in the world trade center (wtc) clinical program have a clinical syndrome characterized by chronic obstruction in small airways and persistence of lower respiratory symptoms despite therapy. this study will test the hypothesis that persistent symptoms in wtc "survivors" are associated with abnormal small airways whose dysfunction is amplified during exercise and is associated with biologic evidence of inflammation and remodeling. the results from this study will have important treatment implications for our wtc population with potential applicability to larger populations with either inhalational lung injury and/or airway diseases such as asthma and chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: sacos patients * previously participated in ulrs study and signed consent to be recontacted, or * patient in the wtc ehc and signed consent to be recontacted * onset of lower respiratory symptoms (lrs) after 9/11/01 * act \< 20 at wtc ehc monitoring visit * presence of lrs on study visit 1 * act\<20 at study visit 1 * fev1 \> 70% predicted study visit 1 * using ics/laba (advair hfa equivalent \> 115/21 mcg bid) or fluticasone (110 mcg bid or equivalent) for at least 1 month before study visit 1 * cxr without parenchymal abnormalities control * patient in the wtc ehc and signed consent to be recontacted * of lower respiratory symptoms on wtc ehc monitoring visit of wtc ehc * absence of lower respiratory symptoms on study visit 1 * fev1 \> 70% predicted on monitoring * not on any ics/laba/lama exclusion criteria: sacos * \>10py tobacco use * unstable cardiac disease * systolic bp \> 180 mmhg or diastolic bp \> 120 mmhg * oxygen saturation \< 90% * uncontrolled htn, dm * musculoskeletal inability to exercise * use of long acting muscarinic antagonist in the past 2 weeks * current use of oral corticosteroids * other pulmonary disease, including sarcoidosis, ild * currently pregnant or with plans to become pregnant or lactating * history of narrow angle glaucoma * known prostate hyperplasia or bladder-neck obstruction control * \>10py tobacco use * unstable cardiac disease * systolic bp \> 180 mmhg or diastolic bp \> 120 mmhg * oxygen saturation \< 90% * uncontrolled htn, dm * musculoskeletal inability to exercise * use of ics/laba/saba/lama individually or in combined formulation * current use of oral corticosteroids * other pulmonary disease, including sarcoidosis, ild * currently pregnant or with plans to become pregnant or lactating * history of narrow angle glaucoma * known prostate hyperplasia or bladder-neck obstruction

Keywords: world trade center world trade center survivors